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A Trial of Intranasal Ketamine for the Treatment of Obsessive-Compulsive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02234011
Recruitment Status : Terminated (Terminated due to difficulty in recruiting participants.)
First Posted : September 9, 2014
Results First Posted : May 12, 2017
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Brian P. Brennan, MD, Mclean Hospital

Tracking Information
First Submitted Date  ICMJE September 4, 2014
First Posted Date  ICMJE September 9, 2014
Results First Submitted Date  ICMJE January 20, 2017
Results First Posted Date  ICMJE May 12, 2017
Last Update Posted Date May 12, 2017
Actual Study Start Date  ICMJE September 2014
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
Observing if Ketamine May Cause a Decrease in OCD Symptoms [ Time Frame: Baseline to Week 5 ]
Examining if ketamine is associated with a decrease in OCD symptoms as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at completion of one treatment when compared to placebo (saline solution). The Y-BOCS measures OCD symptoms on a scale of 0-40, with higher numbers indicating greater severity of OCD symptoms. For this study, subjects had to have a Y-BOCS of greater than or equal to 18 in order to participate.
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2014)
Decrease in OCD Symptoms [ Time Frame: Baseline to Week 5 ]
Ketamine is associated with a decrease in OCD symptoms as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at completion of one treatment when compared to placebo (saline solution).
Change History Complete list of historical versions of study NCT02234011 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Intranasal Ketamine for the Treatment of Obsessive-Compulsive Disorder
Official Title  ICMJE A Placebo-Controlled Crossover Trial of Intranasal Ketamine for the Treatment of Obsessive-Compulsive Disorder
Brief Summary

This study is being done to learn whether administration of intranasal (inhaled through the nose) ketamine reduces symptoms of obsessive-compulsive disorder (OCD). Ketamine has been approved by the U.S. Food and Drug Administration (FDA) as an anesthetic agent (a medicine to reduce pain during surgery and other procedures) but ketamine has not been approved by the FDA as a treatment for OCD.

The investigators believe that ketamine may be effective in reducing symptoms of OCD due to its ability to decrease the activity of a specific brain chemical called glutamate. Previous studies have shown that people with OCD can have abnormal levels of glutamate in their brains. This is the first time that intranasal ketamine is being studied in people with OCD. However, studies have been done in the past using intravenous (IV; through a needle into a vein in your arm) ketamine in people with OCD, and intranasal ketamine has been studied in people with other psychiatric conditions.

This research study will compare ketamine to placebo. The placebo looks exactly like ketamine, but contains no ketamine. At some time during the study, the investigators will give you ketamine. At another time, the investigators will give you placebo. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-Compulsive Disorder
Intervention  ICMJE
  • Drug: Ketamine
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Ketamine/Placebo
    Participants in this group will receive 5 sprays (10 mg each) of intranasal ketamine for the first treatment visit, then receive 5 sprays of placebo (saline solution) at the second treatment visit two weeks later.
    Interventions:
    • Drug: Ketamine
    • Drug: Placebo
  • Experimental: Placebo/Ketamine
    Participants in this group will receive 5 sprays of placebo (saline solution) for the first treatment visit, then receive 5 sprays (10 mg each) of intranasal ketamine at the second treatment visit two weeks later.
    Interventions:
    • Drug: Ketamine
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 27, 2016)
1
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2014)
20
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female age ≥ 18 and ≤ 55
  2. Meets DSM-IV50 criteria for OCD as the primary presenting diagnosis as determined by the investigator (participants with secondary comorbid dysthymia, major depression, anxiety disorders, eating disorders, and other obsessive-compulsive spectrum disorders will still be eligible for enrollment).
  3. Score of ≥ 18 on the Y-BOCS at screening

Exclusion Criteria:

  1. Unwillingness or inability to provide written informed consent.
  2. Active suicidal ideation at screening
  3. Lifetime history of psychotic disorder or autism spectrum disorder
  4. DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine dependence, within three months prior to screening
  5. Any history of intolerance or hypersensitivity to ketamine
  6. Any history of nasal/sinus anomalies or dysfunction (e.g., nasal obstruction or history of nasal surgery)
  7. Clinically significant medical disease including, but not limited to, cardiac (including uncontrolled hypertension or uncontrolled hypotension, arrhythmias, congestive heart failure, angina), pulmonary, hepatic, renal, or endocrine disorders, which would increase the risk to the participant or interfere with interpretation of results as judged by the principal investigator.
  8. Clinically significant neurologic disease including, but not limited to, seizure disorder, neurodegenerative diseases, transient ischemic attacks, neural vascular disease, stroke, cerebral aneurysms, and history of traumatic brain injury.
  9. Female participants with a positive serum or urine pregnancy test at screening
  10. Pregnancy. Females of childbearing potential must be using an effective contraceptive method (e.g., abstinence, prescription oral contraceptives, contraceptive injections, double-barrier method, male partner sterilization). Women that are not of childbearing potential are defined as: postmenopausal (>45 years of age with amenorrhea for at least 12 months, or any age with menorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level >40 IU/ml); permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy.
  11. Female participants who are lactating.
  12. Any screening laboratory abnormality deemed clinically significant by the investigator
  13. Currently taking opiate pain medications, dextromethorphan, St. John's Wort, theophylline, or tramadol.
  14. Any participation in an investigational drug trial within 30 days of enrollment in study.
  15. Contraindication to having an MRI.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02234011
Other Study ID Numbers  ICMJE 2014P001140
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brian P. Brennan, MD, Mclean Hospital
Study Sponsor  ICMJE Mclean Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brian P Brennan, M.D. Mclean Hospital
PRS Account Mclean Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP